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Antiphospholipid Antibodies and Early Severe Preeclampsia.

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ClinicalTrials.gov Identifier: NCT01538121
Recruitment Status : Unknown
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2012
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.

Condition or disease
Severe Preeclampsia Antiphospholipid Syndrome

Study Design

Study Type : Observational
Estimated Enrollment : 310 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
Study Start Date : June 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : August 2016


Groups and Cohorts

Group/Cohort
Cases-Early Severe Preeclampsia
Patients with severe preeclampsia before 34 weeks of gestation
Controls
Patients with normal pregnancies at term.


Outcome Measures

Primary Outcome Measures :
  1. Lupus anticoagulant [ Time Frame: 15 months ]
    Number of cases positive for Lupus Anticoagulant.

  2. Anticardiolipin antibodies [ Time Frame: 15 months ]
    Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.

  3. B2 Glycoprotein I [ Time Frame: 15 months ]
    Number of cases with levels of B2 Glycoprotein 1 > 99%


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients admitted for severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).
Criteria

Inclusion Criteria:

  • Gestational age between 24-34 weeks
  • Diagnosis of severe preeclampsia

Exclusion Criteria:

  • Known antiphospholipid syndrome.
  • Known presence of antiphospholipid antibodies.
  • Patients with systemic lupus erythematosus.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538121


Locations
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
More Information

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01538121     History of Changes
Other Study ID Numbers: MHST2012-01A
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Antibodies, anticardiolipin
Antibodies, B2 Glycoprotein I
Lupus Anticoagulant
Severe Preeclampsia

Additional relevant MeSH terms:
Pre-Eclampsia
Antiphospholipid Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs